Union health ministry has eased norms on the sale of the antiviral medicines used to treat H1N1 (swine flu) to make them more widely available.
H1N1 is the dominant flu strain causing seasonal flu this year worldwide, including in India. Till mid-June, India reported 525 deaths and 10,812 cases, with western and southern India the worst affected.
A new notification now allows all pharmacies to stock oseltamivir, the sale of which so far had been restricted to a handful of chemists in large hospitals and pharmacies to prevent misuse and overuse.
Patients still need a signed and stamped prescription from a registered medical practitioner to buy the medicine.
During the H1N1 pandemic in 2009, the health ministry put antiviral medicines in the schedule X drug category that permits a limited number of pharmacies with special licences to sell it.
In its notification, the Drug Controller General of India says it’s acting upon recommendations of the joint monitoring group and is withdrawing antivirals oseltamivir and zanamivir from the list of schedule X drugs.
Both drugs “…are now permitted for sale as similar to drugs under schedule H1 of Drugs and Cosmetics Act and rules,” a section of the notification reads.
More pharmacies in the country sell schedule H1-category medicines as compared to schedule X category that require a special licence.
{{/usCountry}}More pharmacies in the country sell schedule H1-category medicines as compared to schedule X category that require a special licence.
{{/usCountry}}Over-the-counter sale without a prescription from a registered medical practitioner continues to be banned and pharmacies are still required to keep a record of the stock sold.
“The idea behind restricting its sale earlier was to ensure there was no misuse of the medicine as the risk of people developing resistance to the drug, if they popped it randomly, was high,” said a senior health ministry official, requesting anonymity.
“The move to withdraw it from the X-category automatically increases the number of pharmacies allowed to sell both the antivirals, which in effect means there is better access to these medicines,” says the official.
As a precautionary measure, the manufacturer will have to submit a monthly statement to the drug controller, ‘containing therein the quantity of such drugs supplied by them to distributers, stockists and dealers and the quantity of medicine left with them”.
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